ENT solutions. Face fewer. boundaries

Transcription

1 ENT solutions Face fewer boundaries

2 ENT solutions Balloon dilation XprESS ENT dilation system 01 PathAssist LED Light Fiber sinus confirmation tool 03 Nasal implant LATERA absorbable nasal implants 01 Imaging FocESS imaging solutions 04 FocESS sinuscopes 05 Cyclone sinonasal suction and irrigation system 09 MiniFESS turbinate forceps 10 MiniFESS Blakesley thru-cut forceps 11 MiniFESS Blakesley forceps 12 MiniFESS Takahashi forceps 13 MiniFESS sickle knife 14 MiniFESS maxillary seekers 15 MiniFESS sphenoid seeker/freer 16 MiniFESS Light Seeker sinus confirmation tool 17 MiniFESS surgical instrument sets 18 Entellus Medical shaver system Entellus Medical shaver system components Entellus Medical reinforced anesthesia needle 19 Navigation Fiagon ENT navigation systems 01 Fiagon ENT navigation system consumables 07 Nasal packing XeroGel nasal dressing/epistaxis pack 20 To order please call

3 Balloon dilation XprESS ENT dilation system Balloon dilation PathAssist LED Light Fiber sinus confirmation tool Pull tab XprESS Ultra ENT dilation device XprESS LoProfile ENT dilation device PathAssist LED Light Fiber XprESS Ultra ULF-105 5mm x 20mm XprESS Ultra ULF-106 6mm x 20mm XprESS Ultra ULF-205 5mm x 8mm XprESS Ultra ULF-206 6mm x 8mm XprESS LoProfile LPLF-105 5mm x 20mm XprESS LoProfile LPLF-106 6mm x 20mm XprESS LoProfile LPLF-107 7mm x 20mm XprESS LoProfile LPLF-205 5mm x 8mm XprESS LoProfile LPLF-206 6mm x 8mm Product Catalog No. Description LED Light Fiber LFLED-100 LED Light Fiber XprESS ENT dilation system Indication for Use: To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach. LED Light Fiber Indications for Use: To locate, illuminate within, and transilluminate across nasal and sinus structures. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events. A physician using XprESS for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use XprESS for Eustachian tube dilation does not meet at least one of these criteria, please contact your Entellus Medical representative to arrange training. PathAssist LED Light Fiber Indications for Use: To locate, illuminate within, and transilluminate across nasal and sinus structures. Please see the Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events. 1 2

4 Nasal implant LATERA absorbable nasal implants Imaging FocESS imaging solutions LATERA absorbable implant FocESS HD wireless camera Monitor on Entellus Medical cart LATERA implant LATSYS01 1 system LATERA implant LATSYS03 3 systems LATERA implant LATSYS01 6 systems Product Catalog No. Description FocESS HD wireless camera WCS-100 Includes receiver, battery charger, and 2 batteries Entellus Medical cart SC-100 Fully assembled medical cart; mounts up to a 32 monitor Monitor, 32 OPM HD monitor Monitor, 23 OPM HD monitor FocESS HD wireless camera Indications for Use: The FocESS HD wireless camera is indicated for use in endoscopic procedures to allow visualization of the nasal and sinus cavities when used with an appropriately indicated endoscope. Intended Use: The FocESS HD wireless camera is intended for use in a physician s office during endoscopic sinus examinations and procedures. The Wireless Camera is not intended for used in the sterile field. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care. 3 4

5 Imaging FocESS sinuscopes Cyclone sinonasal suction and irrigation system Sinuscope, 0 ES-0 3mm, 0, autoclavable Sinuscope, 30 ES-30 3mm, 30, autoclavable Sinuscope, 45 ES-45 3mm, 45, autoclavable Sinuscope, 70 ES-70 3mm, 70, autoclavable Sterilization tray TRA-102 Sterilization tray for FocESS sinuscopes; autoclavable; holds 3 sinuscopes, 6 light post adapters Cyclone system CC-100 Single-handed, provides simultaneous irrigation and suction FocESS Indications for Use: The FocESS sinuscope if intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. The Sinuscope is indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facioplastic surgery. FocESS sinuscope Sterilization Tray Indications for Use: The FocESS sinuscope Sterilization Tray is used to organize and protect the FocESS sinuscopes that are sterilized by a healthcare provider. The FocESS sinuscope Sterilization Tray is intended to allow sterilization of the enclosed medical devices during these sterilization cycles: prevacuum steam, STERRAD 100S Standard, STERRAD 100NX Standard, ethylene oxide, STERRAD NX Standard, STERRAD 100NX Express. The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on its own to maintain sterility. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. 5 6

6 MiniFESS turbinate forceps MiniFESS Blakesley thru-cut forceps Straight 45 Turbinate forceps CS mm working length, 5x19mm jaws Thru-cut forceps CS-102 Straight, 110mm working length, 2x5mm jaws Thru-cut forceps CS , 110mm working length, 2x5mm jaws Please see instructions for cleaning, sterilizing and care for surgical instruments. Please see instructions for cleaning, sterilizing and care for surgical instruments. 7 8

7 MiniFESS Blakesley forceps MiniFESS Takahashi forceps Straight Forceps CS-106 Straight, 110mm working length, 2.5x7mm jaws Forceps CS , 110mm working length, 2.5x7mm jaws Forceps CS , 110mm working length, 2.5x7mm jaws Forceps CS-104 Straight, 2.5x8mm jaws Please see instructions for cleaning, sterilizing and care for surgical instruments. Please see instructions for cleaning, sterilizing and care for surgical instruments. 9 10

8 MiniFESS sickle knife MiniFESS maxillary seekers Sickle knife CS mm curved blade Maxillary seeker MS angle Maxillary seeker MS angle Maxillary seeker set MS-255 Includes both 120 angle and 135 angle Please see instructions for cleaning, sterilizing and care for surgical instruments. Please see instructions for cleaning, sterilizing and care for surgical instruments

9 MiniFESS sphenoid seeker/freer MiniFESS Light Seeker sinus confirmation tool Angle: 78 The Light Seeker has a standard ACMI connection; 2 converter adapters are provided Connections: ACMI, Wolf and Storz Wolf adapter Storz adapter Portable red LED light source Sphenoid seeker/freer FS-100 Sphenoid seeker/freer Light Seeker IS , 1.5mm ball tip, includes standard ACMI connection plus 1 Wolf and 1 Storz connector adapter Entellus Medical portable red LED light source PRLS-100 Portable, non-sterile, reusable light source to be used with the MiniFESS Light Seeker, includes 2 batteries and 1 battery charger Portable Red LED Light Source Indication for Use: The Portable Red LED Light Source is indicated for use in endoscopic procedures to locate, illuminate within, and transilluminate across nasal and sinus structures when used with the MiniFESS Light Seeker. Portable Red LED Light Source Intended Use: The Portable Red LED Light Source is intended for use in a physician s office during endoscopic procedures. The Portable Red LED Light Source is not intended for use in the sterile field. Light Seeker Indications for Use: The Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over. Please see instructions for cleaning, sterilizing and care for surgical instruments. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events

10 MiniFESS surgical instruments Entellus Medical shaver system Shown: CST-1000 and PASS-100 combined Surgical instrument set CST-1000 Includes 1 Blakesley thru-cut forceps (straight, 45 ), 1 Takahashi forceps, 1 turbinate forceps, 1 sickle knife, 3 Blakesley forceps (straight, 45, 90 ), and 1 sterilization tray Surgical instrument set PASS-100 Includes 2 maxillary seekers (120 and 135 angle), 1 sphenoid seeker/freer, and 1 Light Seeker Sterilization tray TRA-101 Autoclavable, holds 8 finger-grip and 6 seeker-style instruments Shaver system SS-100 Shaver system Shaver blade SSB mm, single use, straight, 5 pack Shaver blade SSB mm, single use, straight, 5 pack Shaver blade SSB mm, single use, 40 curved, 5 pack Shaver blade SSB mm, single use, 40 curved, 5 pack Shaver blade SSB mm, single use, 60 curved, 5 pack Shaver blade SSB mm, single use, 60 curved, 5 pack Shaver blade SSB mm, reusable, straight Light Seeker Indications for Use: The Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over. MiniFESS Sterilization Tray Indications for Use: The MiniFESS Sterilization Tray is used to organize and protect the MiniFESS instruments that are sterilized by a healthcare provider. The MiniFESS Sterilization Tray is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on its own to maintain sterility. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments. Entellus medical shaver system Indications for Use: The Entellus medical shaver system has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments

11 Entellus Medical shaver system components Entellus Medical reinforced anesthesia needle Aquacare cleaning fluid pack Aquacare cleaning fluid pack Lubrifluid lubricant pack Lubrifluid lubricant pack Blade cleaning brushes SSA pack Control unit SSA-101 Control unit Foot pedal SSA-102 Foot pedal Power cord SSA-103 Power cord Handpiece SSA-104 Handpiece Irrigation stand SSA-105 Irrigation stand Irrigation clips SSA pack Irrigation lines (or SSA-107) Irrigation lines 10 pack Cleaning brush SSA-108 Cleaning brush 10 pack Reinforced anesthesia needle RAN G x 3.5, 5 pack Entellus medical shaver system Indications for Use: The Entellus medical shaver system has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments. Indications for Use: For use in injecting local anesthetics into a patient to provide regional anesthesia. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician

12 Navigation Fiagon ENT navigation systems Imaging and navigation Fiagon ENT navigation system consumables Fiagon GuideWire device Fiagon basic navigation system FSNS-E Includes preinstalledsinus software, system set-up components and 1 universal headrest Fiagon premium navigation system FSNS-E Includes preinstalled sinus, ear, tumor, cranio maxillofacial software, system set-up components and 1 universal headrest Universal headrest N/A Integrated sensor, inclinable; includes adapter for different OR tables; new smaller design sinus software, system set-up components and 1 universal headrest Registration pointer FRP-E Registration pointer Localizer adhesive pad FLAP-E Localizer adhesive pad Navigation instruments, single use GuideWire device FGW-E mm; navigated wire enables tracking of the XprESS LoProfile balloon and XprESS Pro balloon Navigation instruments, 10 ueses FinePointer device FRP-E mm FlexPointer device FRP-E mm FlexPointer device FRP-E mm FlexTube device FRP-E mm FlexTube device FLAP-E mm PointerTube device, Keat FRP-E PointerTube device, Keat PointerTube device, Kennedy FRP-E PointerTube device, Kennedy PointerTube device, sinus frontalis FRP-E PointerTube device, sinus frontalis PointerTube device, Stammberger FLAP-E PointerTube device, Stammberger Adhesive pads FLAP-E pack of adhesive pads PointerShell device FRP-E mm PointerShell device FRP-E mm PointerShell device FRP-E mm PointerShell LS device FRP-E Fits MiniFESS Light Seeker PointerShell device, niversal FLAP-E Adjustable adapter ranging from 2.5-5mm Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician

13 Nasal dressing XeroGel nasal dressing/epistaxis pack XeroGel nasal dressing/packing XeroGel dressing/epistaxis pack XeroGel dressing/epistaxis pack XG-102 XG cm L x 2.4cm W x 0.3cm thickness, box of 2 individual, sterile units 4.0cm L x 2.4cm W x 0.3cm thickness, box of 8 individual, sterile units XeroGel Indications for Use: XeroGel is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces; including during mesothelialcell regeneration in the nasal cavity; Help control minimal bleeding following surgery or trauma; Help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. XeroGel is indicated for use as a nasal packing to treat epistaxis. XeroGel Contraindications: This product is contraindicated for use in patients with a known hypersensitivity/allergy to shellfish. Refer to XeroGel Instructions for Use (IFU) for a complete listing of precautions and possible adverse effects 21

14 ENT Stryker Corporation or its affiliates own, use, or have applied for the following trademarks or service marks: Cyclone, Entellus Medical, FoCESS, LATERA, Light Fiber, Light Seeker, MiniFESS, PathAssist, Stryker, XeroGel and XprESS. All other trademarks are trademarks of their respective owners or holders. The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker s trademark or other intellectual property rights concerning that name or logo ra 10/2018 Copyright 2018 Stryker Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN O F ent.stryker.com